The 21st Century Cures Act: One of Many Reasons Why Today’s Executive Order Is Misguided

By Rachel Sachs

Today, President Trump signed an executive order (EO) whose purpose is ostensibly to reduce the regulatory burden imposed by the government on many different types of industries.  The EO envisions achieving this goal through an incredibly sophisticated strategy: “for every one new regulation issued, at least two prior regulations be identified for elimination.”  Not how burdensome any particular regulation is, or how old it is, or how broad it is – just how many regulations there are.

The next question, of course, is what the EO means by “regulation.”  It clearly includes traditional APA notice-and-comment rulemaking (the EO specifically calls out situations when an agency “publicly proposes for notice and comment” a regulation).  More generally, the EO does provide a definition: “For purposes of this order the term “regulation” or “rule” means an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

This sounds to me as if it includes guidance documents, which are used extensively by many agencies to set and implement policy. To be sure, it is not always clear what counts as a guidance document, and it is not always clear whether agencies are attempting to use guidance to circumvent the notice-and-comment rulemaking process.  But by many common definitions of guidance documents (including those put forth in executive orders by the Bush Administration, for instance), the term “regulation” as defined in this EO would seem to include guidance documents.  As with other EOs issued in the past week, this one could have benefited from more clarity, but I think the better reading of the EO is that it does cover guidance.

There are many reasons why this strategy in general is a bad one, but I’ll focus on just one: the need to develop policy as a result of particular statutes.  Take the 21st Century Cures Act.  Whatever your view of its merits, it passed with overwhelming bipartisan support in the last weeks of President Obama’s administration.  It also imposes enormous new obligations on HHS and the FDA to make all kinds of policy judgments going forward.  It rarely requires the creation of a traditional notice-and-comment rulemaking (see sections 4002 and 4003 for examples), but often speaks in terms of “establish[ing] a program” or “establish[ing] a draft framework,” much of which could be done through guidance.

Continue reading

Housing Equity Week in Review

Last week, January 23-29, 2017, saw a mix of national and local-level housing news. Here’s our round-up for the past week:

  • Surprising some on the “Warren-wing” of the Democratic Party, Elizabeth Warren came out in support of Dr. Ben Carson as the 17th Secretary of Housing and Urban Development. In the confirmation hearing, Warren asked Carson if he can promise that no taxpayer dollar will go from HUD to developments’ of Donald Trump, then pointing out that it was a trick question since there was no financial disclosure,  no one knows exactly what how or what President Trump benefits from financially. However, due to promises to abate lead in housing and to protect from LGBTQ discrimination in housing markets, Warren decided not to stand in Carson’s way. Coverage via The Hill.
  • President Trump’s pick for Secretary Treasury, Steve Mnuchin, lied during his confirmation hearing about foreclosure practices of One West Bank while he was the chairmen and CEO, according to the Columbus Dispatch.
  • As the population ages, housing needs change. Are we keeping up with the new demand? New York Times opinion piece on the housing needs of the elderly.
  • Bay Area housing prices are going down due to building boom, via the Business Journal.
  • The National Low Income Housing Coalition released a statement in opposition of the Local Zoning Decisions Protection Act of 2017.

Did we miss anything? Let us know!

Erin Fuse Brown on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5

This week features Professor Erin C. Fuse Brown of Georgia State University’s College of Law. We discussed her fascinating work on the law & policy of consumer protection in health care, including the new article “Consumer Financial Protection in Health Care.”

Our discussion centered on surprise medical bills (including balance billing),“inscrutable price opacity,” and medical debt collection. This is a difficult area and one that implementers of the ACA have only begun to confront. Looking forward, our consensus was that this increasingly will become the province of “bifurcated” state laws passed under the specter of ERISA preemption–which could leave those in self-insured plans at the mercy of their employers.

For a thoughtful perspective on cutting edge efforts to protect patients from surprise bills and opaque billing, there is no better resource. And be sure to check out her SSRN Page for other important work on ongoing efforts to bend the cost curve in health care and assure more universal access to care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw